LYSODREN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

MITOTANE

Boleh didapati daripada:

HRA PHARMA RARE DISEASES

Kod ATC:

L01XX23

INN (Nama Antarabangsa):

MITOTANE

Dos:

500MG

Borang farmaseutikal:

TABLET

Komposisi:

MITOTANE 500MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0113395001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2020-04-03

Ciri produk

_LYSODREN Tablets, 500 mg _
_Page 1 of 25_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LYSODREN®
Mitotane tablets
Tablets, 500 mg, oral administration
Antineoplastic Agent
HRA Pharma Rare Diseases
200 Avenue de Paris
Châtillon, France 92320
Date of Initial Authorization:
DEC 31, 1979
Date of Revision:
SEPT 25, 2023
Submission Control Number: 275256
_ _
_LYSODREN 500 mg Tablets _
_Page 2 of 25_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.1 Dosing Considerations
09/2023
4 Dosage and Administration, 4.2 Recommended Dose and Dosage
Adjustment
09/2023
4 Dosage and Administration, 4.4 Administration
09/2023
7 Warnings and Precautions, Endocrine and Metabolism
09/2023
7 Warnings and Precautions, General
09/2023
7 Warnings and Precautions, Hematologic
09/2023
7 Warnings and Precautions, Hepatic/Biliary/Pancreatic
09/2023
7 Warnings and Precautions, Monitoring and Laboratory Tests
09/2023
7 Warnings and Precautions, Peri-Operative Considerations
09/2023
7 Warnings and Precautions, Renal
09/2023
7 Warnings and Precautions, 7.1.1 Pregnant Women
09/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics (<18 years of age)
...................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...................................